A pilot study to examine factors associated with excessive gagging in denture patients. A randomised controlled trial
| ISRCTN | ISRCTN36747800 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36747800 |
| Secondary identifying numbers | N0013146125 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 20/10/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael Fenlon
Scientific
Scientific
Dental Prosthetics
Room 304, 25th Floor, Guy's Tower
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom
| Phone | +44 (0)20 7188 7479 |
|---|---|
| michael.fenlon@kcl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | That there is no difference between the success of and impact on oral health of patients of lower cobalt chromium distal extension saddle partial dentures and single cantilever distal extension resin bonded bridges. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health |
| Intervention | Patients suitable for cobalt chromium lower distal extension saddle partial dentures made at Guy's Hospital will be randomised into two groups: 1. One group will have the dentures 2. The other will have one or two distal cantilever minimum preparation resin bonded bridges The success, ongoing problems, maintenance requirements and impact on oral health of the different restorations will be monitored over 5 years. |
| Intervention type | Other |
| Primary outcome measure | 1. Fit of dentures 2. Need for adjustment, 3. Acceptability 4. Patient wear of dentures |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/03/2004 |
| Completion date | 30/09/2007 |
| Reason abandoned (if study stopped) | Lack of funding |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 100 |
| Key inclusion criteria | 100 patients attending Guy's Hospital for prostheses for edentulous distal extension saddle areas. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2004 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Dental Prosthetics
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Guy's and St. Thomas' NHS Foundation Trust (UK)
No information available
Own account - NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
